510(k) Report

Devices descending from K130548

602 later devices reach Epicage Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+1K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+1K132601Coroent Sterile Implants SystemNu Vasive, Incorporated2013596—
+2K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K141896Coroent SystemNu Vasive, Incorporated2014480—
+2K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+2K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+2K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated2014483—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K261049Scala® TLSpineart SA20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181397DualXInnovasive, Inc.201815—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—